UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011890 |
|---|---|
| Receipt number | R000013899 |
| Scientific Title | A pilot study to evaluate the efficacy of lafutidine in patients with paclitaxel-induced peripheral neuropathy. |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2013/09/27 15:46:06 |
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Basic information
Public title
A pilot study to evaluate the efficacy of
lafutidine in patients with paclitaxel-induced
peripheral neuropathy.
Acronym
A pilot study to evaluate the efficacy of
lafutidine in patients with paclitaxel-induced
peripheral neuropathy.
Scientific Title
A pilot study to evaluate the efficacy of
lafutidine in patients with paclitaxel-induced
peripheral neuropathy.
Scientific Title:Acronym
A pilot study to evaluate the efficacy of
lafutidine in patients with paclitaxel-induced
peripheral neuropathy.
Region
| Japan |
Condition
Condition
gynecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of lafutidine in
gynecological cancer patients with paclitaxelinduced
peripheral neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Short-form McGill Pain Questionnaire(SFMPQ)
Patient Neurotoxity Questionnaire(PNQ)
Key secondary outcomes
Peripheral neuropathy evaluated by CTCAE
v4.02
Adverse drug reaction of lafutidine
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lafutidine is administered orally twice daily at a dose of 10 mg for 12 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Gynecological cancer patients with
paclitaxel-induced peripheral neuropathy
(>=Grade1).
(2) Patients with gastric or esophageal lesion.
(gastric ulcer or reflux esophagitis.)
(3) Age of 20 years or older.
(4) ECOG Performance Status (PS) of 0 - 2.
(5) Sufficient oral intake.
(6) Written informed consent.
Key exclusion criteria
(1) Current use of other anti-ulcer drugs.
(2) Pregnant females and nursing mothers.
(3) With history of severe drug allergies.
(4) Physician concludes that the patient's
participation in this trial is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiya Fujimori |
Organization
Fukushima Medical University, School of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima
TEL
024-547-1111
fujimori@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenori Furukawa |
Organization
Fukushima Medical University, School of medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima
TEL
024-547-1111
Homepage URL
s-furu@infoseek.jp
Sponsor or person
Institute
Fukushima medical University Hospital,
School of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013899
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
